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FDA Strengthens Warnings on Sleeping Pills


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Since little is known about the long-term side effects of these sleep medications, the FDA should make the drug companies do long-term studies on the potential risks, Jacobs said.

"The side effects that the drug companies have studied are based only on short-term studies," he said. "The typical study on sleeping pills averages seven days, but the majority of people who take sleeping pills take them, on average, for 24 months, and a third use them for five years."

Jacobs also said he thinks the number of people who experience sleep-behavior side effects is underreported "because many people don't remember having them."

Text Continues Below



"In my practice, 10 percent of people who take sleeping pills have reported some kind of side effects that involve amnesia. The only way they know it is that a family member tells them about it," he said. "If somebody lives on their own, they don't know it."

More than 20 million Americans suffer from chronic insomnia, which is defined as poor sleep every night or most nights for more than six months, according to the American Insomnia Association.

According to Consumer Reports, pharmacists filled 43 million prescriptions for sleep drugs in 2005, a 32 percent increase from 2001. Prescription insomnia medications brought pharmaceutical companies more than $2.7 billion in 2005.

More information

For more information on sleep disorders, visit the U.S. National Library of Medicine.

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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 3/14/2007

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SOURCES: Gregg Jacobs, Ph.D., insomnia specialist, Sleep Disorders Center, Beth Israel Deaconess Medical Center, and assistant professor, psychiatry, Harvard Medical School, Boston; March 14, 2007, teleconference with Russell Katz, M.D., director, U.S. Food and Drug Administration, Division of Neurology, Office of Drug Evaluation I, Center for Drug Evaluation and Research, Washington, D.C.


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